NL-OMON45620撤回2 期
Modulating regulatory T cell function in Juvenile Idiopathic Arthritis with Vitamin B3 (nicotinamide): a phase I/II trial focusing on safety and feasibility aspects in children with JIA. - B-Vit in JIA trial
niversitair Medisch Centrum Utrecht0 个研究点目标入组 45 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17(—)
入选标准
- •- Patients with a diagnosis of oligo-articular or poly-articular JIA with active disease in 1 or multiple joints and an indication for intra-articular corticosteroid injection.
- •- Age between 4 to 18 years
- •- At the moment of inclusion, not on non-biological DMARD (Methotrexate) treatment or on stable DMARD treatment (at least 3 months of stable Methotrexate use).
排除标准
- •- no informed consent possible by patient/parents or caregivers
- •- participation in other interventional trials
- •- Treatment with biological DMARD
- •- Recently started treatment with non-biological DMARD (Methotrexate). Defined as treatment for a period less than 3 months.
- •- Use of systemic corticosteroids
- •- Relevant co morbidity: raised liver enzymes (>2x upper limit) and/or evidence of bone marrow failure (pancytopenia based upon full blood count).
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